Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The SX-ELLA Stent Esophageal Degradable BD (BD Stent) is designed for dilation of benign esophageal lesions, namely: (1) stenosis (peptic, anastomotic or caustic) refractory to standard therapy, (2) achalasia refractory to standard therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stenting Arm | Experimental | Stenting Arm |
|
| Dilation Arm | Active Comparator | Dilation Arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stenting with ELLA Biodegradable stent | Device | Treating benign esophageal lesions with the placement of a degradable stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| The average number of dilations per patient within 3 months / 6 months following placement of an ELLA stent | 3 - 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients remaining dysphagia and stricture free within 6 and 12 months after inclusion | 6 - 12 months | |
| Time to recurrent significant dysphagia | 6 - 12 months | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter D. Siersema, MD, PhD | University Medical Center Utrech | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Universitaire Saint Luc | Brussels | 1000 | Belgium | |||
| University Hospitals Leuven |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29883979 | Derived | Walter D, van den Berg MW, Hirdes MM, Vleggaar FP, Repici A, Deprez PH, Viedma BL, Lovat LB, Weusten BL, Bisschops R, Haidry R, Ferrara E, Sanborn KJ, O'Leary EE, van Hooft JE, Siersema PD. Dilation or biodegradable stent placement for recurrent benign esophageal strictures: a randomized controlled trial. Endoscopy. 2018 Dec;50(12):1146-1155. doi: 10.1055/a-0602-4169. Epub 2018 Jun 8. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004940 | Esophageal Stenosis |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard Dilations | Procedure | Treating benign esophageal lesions with standard dilation therapy |
|
|
| Time to dilation of recurrent stricture |
| 6 - 12 months |
| 6 months and 12 months incidence of repeat dilation | 6 - 12 months |
| Serious and minor adverse events with possible or likely relation to the study Intervention | 6 - 12 months |
| Direct medicals costs: procedures, secondary interventions | 6 - 12 months |
| Quality of Life | 6 - 12 months |
| Technical success | Observing proper deployment and placement of stent using endoscopic and radiographic imaging. | 6 - 12 months |
| Assessment of presence of gold markers within the region of the esophagus at 3 months, if possible | Assessment of presence of gold markers within the region of the esophagus at 3 months, using radiographic imaging, if possible, to check for remaining sections of stent that have not yet degraded. | 6 - 12 months |
| Leuven |
| 3000 |
| Belgium |
| IRCCS Istituto Clinico Humanitas | Milan | 20089 | Italy |
| Academic Medical Center | Amsterdam | 22700 | Netherlands |
| St. Antonius Hospital | Nieuwegein | Netherlands |
| University Medical Center Utrech | Utrecht | 3508 | Netherlands |
| Hospital General Universitario de Ciudad Real | Ciudad Real | 13005 | Spain |
| University College of London Hospital | London | NW1 2PG | United Kingdom |
| D010038 | Otorhinolaryngologic Diseases |